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VIENNA, Austria – Preliminary safety results from the PERUSE study presented at the European Cancer Congress 2015 (ECC 2015) in Vienna, Austria1, open the door for the taxanes nab-paclitaxel and paclitaxel to be used in HER2-positive patients with metastatic breast cancer.

“Therapy in HER2-positive metastatic breast cancer has been influenced by the CLEOPATRA trial2, which led to the registration of pertuzumab and trastuzumab in the first line setting,” said Professor Jens Huober, Head of the Breast Centre at the University of Ulm, Germany who has shared his views on new steps forward in the treatment of this subset of patients. “The CLEOPATRA trial used only docetaxel,” he added.

“With PERUSE we now know that at least in terms of safety and tolerability we have good alternatives to docetaxel, namely nab-paclitaxel and paclitaxel, which for the majority of patients are probably less toxic,” he said.

Today’s patients with HER2-positive metastatic breast cancer have usually had pre-treatment with trastuzumab in the adjuvant setting. However, in the CLEOPATRA trial, adjuvant trastuzumab was administered to just 11% of patients. In the phase IIIb PERUSE trial, the drug was given to 40% of patients initially diagnosed with stage I–III breast cancer (28% of the overall population). Huober said: “The PERUSE study population is more reflective of the reality in clinical practice than CLEOPATRA.”

The findings will influence decisions regarding treatment in the metastatic setting of HER2-positive patients. Huober said: “Diarrhoea was a common side-effect with pertuzumab/trastuzumab which was observed with all three taxanes. But with docetaxel there was more mucosal inflammation, haematologic toxicity and febrile neutropaenia than with nab-paclitaxel and paclitaxel. The latter two taxanes led to more neuropathy.”

The cardiac safety of all three taxanes was the same. “There was no signal with the other taxanes to indicate that there might be more cardiac toxicity than with the combination of pertuzumab, trastuzumab and docetaxel,” said Huober.

He pointed out that data on efficacy of the treatment are not yet available. “To draw definitive conclusions we need data on the efficacy of the three regimens,” he said. “However, the first phase II data confirmed paclitaxel weekly combined with pertuzumab and trastuzumab as a highly active regimen with a median progression-free survival of 19.5 months.”

Huober concluded: “The PERUSE trial confirms that in terms of safety and tolerability the combination of pertuzumab and trastuzumab can be applied with other taxanes besides docetaxel, increasing the treatment options for patients with HER2-positive metastatic breast cancer.”